(102 days)
The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
The Corin Unipolar Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is designed to be used with a number of femoral hip stem designs which incorporate a compatible male taper. The Corin Unipolar Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm and a variety of offsets.
Please find below the requested information regarding the acceptance criteria and study details for the Corin Unipolar Modular Head, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | Manufactured from Cobalt-Chrome alloy conforming to ASTM F75. |
| Geometry | Polished, truncated sphere with a high tolerance internal female taper. |
| Dimensional Range (Diameters) | Available in diameters ranging from 40-56mm. This range falls within those cleared for predicate devices (ULTIMA and Unitrax). |
| Dimensional Range (Offsets) | Available in a variety of offsets. This range falls within those cleared for predicate devices (Unitrax). |
| Taper Compatibility | Designed to be used with femoral hip stem designs incorporating a compatible male taper. Internal taper substantially equivalent to Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeves and Osteonics Ion Implanted Femoral Bearings. |
| Mechanical Performance | Demonstrated through Finite Element Analysis, mechanical fatigue testing, and mechanical axial pull-off. |
| Safety and Effectiveness | Results of non-clinical testing and analysis show the device is "expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Non-Clinical Testing: Non-clinical testing and analysis included Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off and dimensional comparison." No specific sample size for a "test set" in the context of clinical data is mentioned, as the evaluation was based on non-clinical engineering and material testing. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable to this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation relied on engineering and material testing standards, not clinical expert consensus for ground truth.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was based on established engineering principles, material standards (e.g., ASTM F75), and the performance characteristics of legally marketed predicate devices. The objective was to demonstrate substantial equivalence, meaning the new device performs similarly to or better than existing, cleared devices.
8. The sample size for the training set
Not applicable. This device's evaluation did not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.